Centerline Biomedical, Inc. (Centerline) announced Tuesday the completion of the first surgical case in its MOTION clinical study of its innovative Intra-Operative Positioning System (IOPS™) surgical navigation platform. The FDA-cleared technology is already being deployed in a controlled launch at Cleveland Clinic and other leading institutions in the United States. The MOTION study will be used to support the company’s submission for market clearance in Europe and other international markets.
First clinically deployed overseas in 2019, and with many cases completed in the US in 2020, IOPS™ is used during endovascular aortic interventions and allows navigation and placement of catheters and guidewires with reduced dependence on X-ray fluoroscopy, to which it serves as an adjunct, providing high-definition 3-D color image guidance using electromagnetic tracking much like a miniaturized form of GPS.
The primary objective of the MOTION study is to formally clinically evaluate the effectiveness and safety of the technology in providing accurate navigation during endovascular aortic repair (EVAR) procedures. The study will consist of 30 total cases divided among Cleveland Clinic and UNC Medical Center.